Tacrolimus Ointment 0.03%
37 adverse event reports submitted to the FDA
Active Ingredients
Administration Routes
Species Affected
Most Affected Breeds
Most Reported Reactions
Outcome Breakdown
Data Summary
| Metric | Value |
|---|---|
| Total adverse event reports | 37 |
| Reports involving death | 2 |
| Case-fatality rate (reported events) | 540.0% |
| Distinct species in reports | 1 |
| Distinct breeds in reports | 20 |
| Distinct reactions reported | 20 |
| Active ingredients on file | 1 |
Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.
Tacrolimus Ointment 0.03% Adverse Event Insights
The FDA Center for Veterinary Medicine database currently holds 37 adverse event reports referencing Tacrolimus Ointment 0.03%, including 2 reports in which the animal died — a 540.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Tacrolimus Ointment 0.03%. Reported administration routes include Unknown, Ophthalmic, Intraocular, Topical. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.
The species most frequently named in Tacrolimus Ointment 0.03% reports are Dog (37 reports), with Dog accounting for the largest share. Within those species, Spaniel - Cocker American (4), Bulldog (4), Shih Tzu (3) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.
The most commonly reported clinical signs associated with Tacrolimus Ointment 0.03% are Emesis (14), Vomiting (6), Lethargy (see also Central nervous system depression in 'Neurological') (5), Lack of efficacy - NOS (5). Of the 37 reports with a coded outcome, Recovered/Normal is the leading category at 54.1%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Tacrolimus Ointment 0.03%.
Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates
Read our methodology — how this data is sourced, computed, and verified.